A Phase II, Single-Arm Trial of Naked Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients with Waldenström's Macroglobulinemia
ESTADO CLÍNICO
En marcha
FASE/S DEL ENSAYO
Fase II
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Macroglobulinemia de Waldenström, Mieloma Múltiple y otras gammapatías, Leucemia mieloide crónica, Linfoma, Leucemia
FECHA DE APERTURA
Mayo, 2005
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Waldenström's Macroglobulinemia (WM) is an uncommon B-cell lymphoproliferative disorder that predominantly involves older patients with a slight male preponderance. WM resembles myeloma and chronic lymphocytic leukemia, but has been described as a low-grade lymphoplasmacytic lymphoma characterized by its over production of monoclonal immunoglobulin M (IgM).
CRITERIOS DE EXCLUSIÓN
No especificado
DESCRIPCIÓN
Toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria, version 3.0. Treatment responses will be categorized according to response criteria from 2nd International Workshop on WM. Treatment efficacy will be assessed by overall response rates (PR, CR) as well as duration of response and time-to-progression; safety, from adverse events, toxicity, and changes in vital signs or laboratory values; pharmacokinetics, from IMMU-103 levels; pharmacodynamics, from B-cell levels; and immunogenicity, from HAHA titers.
PALABRAS CLAVE
chronic leukemia, leukemia, lymphocytic, lymphoma, lymphoplasmacytic lymphoma, myeloma
